Thursday, September 17, 2009

By David Kirby (Click HERE to read and comment on the HuffPo version of this post.)

“The science is largely complete. Ten epidemiological studies have shown MMR vaccine doesn’t cause autism; six have shown thimerosal doesn’t cause autism.”-- Dr. Paul Offit, “Autism’s False Prophets”“16 studies have shown no causal association between vaccines and autism, and these studies carry weight in the scientific industry.”-- Dr. Nancy Snyderman, NBC Today Show Medical EditorConventional wisdom holds that the autism-vaccine question has been “asked and answered,” and that least 16 large, well-constructed epidemiological studies have thoroughly addressed and debunked any hypothesis that childhood vaccination is in any way associated with an increased risk for autism spectrum disorders.

But there are several critical flaws in such an oversimplified generalization, and they are rarely given close examination by public health experts or members of the media.

To begin with, it is unscientific and perilously misleading for anyone to assert that “vaccines and autism” have been studied and that no link has been found. That’s because the 16 or so studies constantly cited by critics of the hypothesis have examined just one vaccine and one vaccine ingredient. And the studies themselves have critical design flaws and limitations.

The current US childhood immunization schedule calls for 28 injections with 11 different vaccines against 15 different diseases by two years of age. Of those 11 vaccines, only the Measles-Mumps-Rubella (MMR) shot has been studied in association with autism, (although a CDC study of an MMR-plus-chickenpox vaccine did show that the risk for febrile seizures in infants was doubled.)

Meanwhile, those 11 vaccines contain scores of ingredients, only one of which, thimerosal, has ever been tested in association with autism.It is illogical to exonerate all vaccines, all vaccine ingredients, and the total US vaccine program as a whole, based solely on a handful of epidemiological studies of just one vaccine and one vaccine ingredient. It is akin to claiming that every form of animal protein is beneficial to people, when all you have studied is fish.

Now, a new study has shown that giving Hepatitis B vaccine to newborn baby boys more than triples the associated risk of developing an autism spectrum disorder.

An abstract of the study was published in the September, 2009 issue of the respected journal Annals of Epidemiology. In it, Carolyn Gallagher and Melody Goodman of the Graduate Program in Public Health at Stony Brook University Medical Center, NY, wrote that, “Boys who received the hepatitis B vaccine during the first month of life had 2.94 greater odds for ASD compared to later- or unvaccinated boys.” The authors used U.S. probability samples obtained from National Health Interview Survey (NHIS) 1997–2002 datasets.

The conclusion states that: “Findings suggest that U.S. male neonates vaccinated with hepatitis B vaccine had a 3-fold greater risk of ASD; risk was greatest for non-white boys.”The authors noted that an earlier study by them found that hepatitis B vaccination was associated with receipt of early intervention/special education services (EIS); in probability samples of U.S. children, and that “children with autistic spectrum disorder (ASD) comprise a growing caseload for EIS.”

The author’s new study used a different database than their earlier study (NHIS vs. NHANES) and they found same thing, suggesting a validation of their findings.Critics will point out that this sample was limited to boys born before 1999, so the results are only applicable to that U.S. male birth cohort, and that the study’s cross-sectional design limits inferences on causality. Another weakness is that the autism diagnoses were parent reported.

On the other hand, these results are generalizable to US boys age 3-17 born prior to 1999; vaccination status was confirmed through medical records; and there was controlling for confounders that may be associated with care seeking behaviors. (The P-value equaled 0.032) The full manuscript is currently under review by another journal.Assuming that the full manuscript is published in a peer-reviewed journal, it will be among the first university-based population studies to suggest an association between a vaccine and an increased risk for autism. And that would be in direct contradiction to all those MMR and thimerosal studies that purportedly found no such link.Does that mean that Hepatitis B vaccine causes autism? Of course not (though any relative risk above 2.0 is general considered to prove causation in a US court of law).

But there are other studies, both published and greatly anticipated, which might support a hypothesized causal association between HepB vaccine and ASD, at least in boys.Any day now, data culled from CDC's Autism and Developmental Disabilities Monitoring network (ADDM), is expected to be published in the Morbidity and Mortality Weekly Report, and the numbers are expected to put the rate of autism at around 1 in 100, or higher.ADDM researchers examine the education and (when possible) medical records of all eight-year-old children in selected US cities and states. They look only at eight-year-old cohorts to allow time for all diagnoses to be made, reported and counted.So far, ADDM has published data from just two birth cohorts: children born in 1992 (eight-year-olds in 2000) and those born in 1994 (eight-year-olds in 2002). The 1992 cohort revealed an estimated ASD rate of one in 166, or 60-per-10,000. (This has since been revised to 67-per-10,000, or one in 150).But CDC data for the same six ADDM locations showed an increase in ASD from 6.7 for 1992 births to 7.4 for 1994 births. And now the total average number expected to exceed 100-per-10,000 for the 1996 birth cohort, born just two years later. The overarching question, of course, will be, "why?"There are many possible explanations, though a 50% increase in just two years is astonishing, no matter what its cause. One possible answer is the Hepatitis B vaccine, (which also contained 25 micrograms of mercury containing thimerosal up until 2002). Introduced in 1991, it was the first vaccine ever given on a population basis to newborn babies (within the first three hours after delivery) in human history. But according to the CDC's National Immunization Survey, only 8% of infant children received the Hep B vaccine in 1992, when that birth cohort showed an ASD rate of 1-in-150.By 1994, the number of children receiving Hep B vaccine at birth had reached just 27% --and the same cohort showed a 10% ASD increase in locations where both years were measured. But by 1996, Hep B coverage rate had risen to 82%. And that is the cohort whose ASD rate rose to around 100-per-10,000 or more.Correlation, obviously, does not equal causation. But the uptake rate of that particular immunization is at least one environmental factor that did demonstrably change during the period in question. In addition, some recent studies and vaccine court decisions have supported the contention that Hepatitis B vaccine can damage myelin -- the nervous system's main insulating component -- at least in certain genetically susceptible adults and infants. A study published last October in the journal Neurology found that children who received the Hepatitis B vaccine series were 50% more likely to develop "central nervous system inflammatory demyelination" than children who did not receive the vaccine. Most of this increase was due to the Engerix B brand of the vaccine, manufactured by the UK's GlaxoSmithKline. That brand increased the risk of demyelination by 74%, and patients with confirmed multiple sclerosis were nearly three times more likely to develop the disorder. "Hepatitis B vaccination does not generally increase the risk of CNS inflammatory demyelination in childhood," the authors concluded. "However, the Engerix B vaccine appears to increase this risk, particularly for confirmed multiple sclerosis, in the longer term. Our results require confirmation in future studies."Let’s hope that future studies of neonatal HebB administration, demyelinating disorders, and ASD are completed as quickly as possible.

David Kirby is author of Evidence of Harm, a founding contributor to Huffington Post and a contributor to Age of Autism. His next book, Animal Factory: The Looming Threat of Industrial Pig, Dairy, and Poultry Farms to Humans and the Environment will be released within the year and is available now for pre-order at Amazon.

Sunday, April 12, 2009

The British Government has been caught lying in a news report in The Mail on Sunday newspaper yesterday about a proposal to give 8 week old British babies Hepatitis B vaccinations: New vaccination fears over plan to give hepatitis jabs at eight weeks old12th April 2009.A Department of Health spokesman was quoted claiming:-The safety of children is always paramount whenever decisions are taken regarding what vaccines are included as part of the child vaccination programme.“But 8 week old babies are not at risk from Hepatitis B, with the potential exception of babies born to mothers from countries with claimed-to-have high rates of infection. Around 2000 British born infants are already being vaccinated annually in the UK. At risk groups are intravenous “recreational” drug abusers and those who practice unsafe sex - which rules out 8 week old babies.And Hepatitis B vaccine has been shown in many peer reviewed research papers [including from Harvard University - detailed references at end] to be associated with numerous infant deaths in the USA and Europe, multiple sclerosis and numerous chronic auto-immune disorders. These latter include Guillain-Barre syndrome, lupus, rheumatism, blood disorders and chronic fatigue.There has been a criminal judicial investigation in France into the adverse effects of this vaccine. France was the first country to introduce universal Hepatitis B vaccination and saw effects which included the first ever seen and harrowing cases of childhood multiple sclerosis in France.Research also shows that the prevalence of Hepatitis B is low in the UK, consistent with previous estimates and suggesting that many infections were acquired outside the UK. This all suggests Government should concentrate its efforts on effective treatment rather than vaccination of infants against a disease which does not affect them. Proponents of the vaccination claim rates of Hepatitis B infection are “spiralling” but based on “estimates”. Regrettably “estimates” can be “pulled” in one direction or another depending on which direction those responsible for the “estimates” are more interested in seeing them move. And in these circumstances, they can never be justification for vaccinating all babies to protect adult drug abusers and practitioners of unsafe sex.Additionally, UK and EU authorities have withdrawn marketing licences for 6 Hepatitis vaccines claiming a lack of efficacy and and denying in one case [Hexavac] any association with 6 infant deaths in Germany. The deaths were reported in a 2005 research paper as possibly caused by the vaccine: “Unexplained cases of sudden infant death shortly after hexavalent vaccination.” Zinka B, Rauch E, Buettner A, Rueff F, Penning R. - Vaccine. 2005 May 18.The most recent vaccine to lose its authorisation was last week when the Medicines Healthcare regulatory Agency withdrew GlaxoSmithKline’s Hepatitis B Energix B vaccine marketing authorisation with Professor Kent Woods, chief executive of the MHRA stating:-The safety of the vaccine is not in question, but it is suspected to be ineffective.” MHRA recalls GSK’s Hepatitis B vaccine - 07 Apr 2009 - Regulatory Affairs - Hays Pharma NewsThe other most recent vaccine to lose its European marketing authorisation was Quintanrix [also from GSK] in August last year. The other vaccines are: Infanrix [GSK], Hepacare [Celltech] and Primavax [Aventis Pasteur].So if ‘The safety of children is always paramount’ why the British Department of Health is even contemplating such a vaccine for 8 week old babies is beyond comprehension.”But there is worse to come and it shows the UK’s New Labour Government has been irresponsible handing recently from 1st April 2009 legal power to dictate vaccination policy exclusively to the Joint Committee on Vaccination and Immunisation: UK Government Hands Drug Industry Control of Childhood Vaccination. The JCVI regrettably has a demonstrable track-record of recklessness on safety up to and including the present day, as shown in FOI documents: British Government’s Reckless Disregard for Child Health Safety and UK Government Hands Drug Industry Control of Childhood Vaccination.The DoH statement published in The Mail on Sunday is also untrue because:-Under the new law The Health Protection (Vaccination) Regulations 2009 which came into effect on 1st April for England only, the Secretary of State has no power on the grounds of safety to refuse to implement or reverse any Joint Committe on Vaccination and Immunisation recommendationthe JCVI expressly has no remit to take safety into account in its decision-making[that role is supposedly the MHRA's but regrettably they seem to rubber stamp a great deal of what the drug industry come up with - as has been shown time and again and not just with vaccines, but drugs like Seroxat - the "anti-depressant" shown not to work compared to placebo and which causes adolescents to be 3 times more likely to commit suicide]the only consideration the Secretary of State can take into account in rejecting JCVI recommendations is cost-effectiveness - not safetycontrary to the UK Department of Health claims, no childhood vaccines used on British children have ever been tested according to the gold standard of evidence - randomised placebo controlled clinical trials.health officials refuse to ensure large scale studies of total health outcomes between vaccinated and unvaccinated individuals are carried out. These should show differences in overall health between these groups and some medical professionals believe this is because the studies would reveal the unvaccinated are healthier overall and high levels of chronic diseases in vaccinated individuals.there is no clinical benefit to infants from Hepatitis B vaccine but infants are put at risk of the known and unknown adverse effectsthis also means doctors and nurses are being expected to behave unethically and possibly criminally - because no caring parent will consent to a vaccine administered to an 8 week old baby on being told there are risks but no benefitsThe main reason for the new drive to more and more vaccines - and this is well published in the trade press - is that the drug industry has been changing its business model. The financial markets have known for many years the old model would fail - that of patented “blockbuster” drugs:-the drug industry have made vaccines the new growth area because they highly lucrativethey are drugs everyone gets - it is the same business model of Bill Gates’ Microsoft - pretty much everyone has to have Windows software - pretty much everyone gets vax’dand the drug industry has been working hard behind-the-scenes to pursuade everyone - especially legislators - that they are vital when they are not and lobbying for changes in law just like this new law - which was introduced without Parliamentary debate and appears to be unlawful per se: UK Government Hands Drug Industry Control of Childhood VaccinationDr Marc Girard, a specialist in the side effects of drugs and commissioned as a medical expert by French courts in the French criminal investigation into the introduction of universal Hepatitis B vaccination in France, suggests that even in high-endemic countries, the risk/benefit ratio of what he describes as “this unusually toxic vaccine” must be carefully re-assessed.Regarding the health situation in the UK Dr Girard says the conclusion not to vaccinate is obvious. France was the first country to implement universal hepatitis B vaccination in 1994.Whilst other evidence is embargoed by the French Courts, Dr. Marc Girard has also been able to publish a scientific review of the unembargoed evidence of the vaccine’s hazards (Autoimmun Rev 2005; 4: 96-100). Dr Girard shows that French health authorities suppress studies demonstrating serious risks.Dr Girard has previously said:Whilst the risk factors for babies have changed little, there is now impressive evidence that for a preventive measure, hepatitis B vaccine is remarkable for the frequency, variety and severity of complications from its use. The toxicity of this vaccine is so unusual that, even if crucial data are regrettably concealed or covered by Court order, scientific evidence is already far higher than normally needed to justify severe restrictive measures.“______________________________________REFERENCESUK & EU MARKETING AUTHORISATION WITHDRAWALSMHRA recalls GSK’s Hepatitis B vaccine - 07 Apr 2009 - Regulatory Affairs - Hays Pharma NewsPublic Statement on Quintanrix (Common name: diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b conjugate vaccine) Withdrawal of the Marketing Authorisation in the European Union - 29/08/08 - EMEA/424484/08EMEA announces recommendation for suspension of the marketing authorisation for Hexavac - EMEA/297369/2005EMEA Questions and Answers on the suspension of Hexavac - EMEA/304888/2005EMEA Withdrawal of the Marketing Authorisation for the Medicinal Product Hepacare (Triple hepatitis B recombinant vaccine)EMEA/32933/02- 20/12/02Public Statement on Hepacare (Triple hepatitis B recombinant vaccine)17/12/02 - EMEA/32933/02Withdrawal of the Marketing Authorisation for the Medicinal Product Primavax (Diptheria, Tetanus, and Hepatitis B vaccine) - 04/12/00 - EMEA/H/2681/00______________________________________DEATHS, MULTIPLE SCLEROSIS AND OTHER ADVERSE EFFECTS“Unexplained cases of sudden infant death shortly after hexavalent vaccination.” Zinka B, Rauch E, Buettner A, Rueff F, Penning R. - Vaccine. 2005 May 18Vaccinations are considered to be the most effective and safe method preventing infectious diseases. Although hexavalent vaccines like Hexavac((R)) and Infanrix Hexa((R)) are assumed to be well tolerated and safe regarding the rate of immunity [Liese JG, Stojanov S, Berut F, Minini P, Harzer E, Jow S, et al. Large scale safety study of a liquid hexavalent vaccine (D-T-acP-IPV-PRP-T-HBs) administered at 2, 4, 6 and 12-14 months of age. Vaccine 2002;20:448-54; Mallet E, Fabre P, Pines E, Salomon H, Staub T, Schodel F, et al. Immunogenicity and safety of a new liquid hexavalent combines vaccine compared with separate administration of reference licensed vaccines in infants. Pediatr Infect Dis J 2000;19:1119-27], it was noticed that several cases of death occurred shortly after the vaccination. We report six cases of sudden infant death that occurred within 48h after hexavalent vaccination. At post-mortal examination, those cases showed unusual findings, especially in the brain and in laboratory tests. Crude calculations of local epidemiology are compatible with an association between hexavalent vaccination and unusual cases of sudden infant death. If confirmed in systematic studies, our findings would have potentially serious clinical implications.Neonatal Deaths After Hepatitis B Vaccine - The Vaccine Adverse Event Reporting System, 1991-1998 - Arch Pediatr Adolesc Med. 1999;153:1279-1282Results: Of 1771 neonatal reports, there were 18 deaths in 8 boys and 9 girls (1 patient unclassified). The mean age at vaccination for these 18 cases was 12 days(range, 1-27 days); median time from vaccination to onset of symptoms was 2 days (range, 0-20 days); and median time from symptoms to death was 0 days (range, 0-15 days). The mean birth weight of the neonates (n = 15) was 3034 g (range, 1828-4678 g). The causes of death for the 17 autopsied cases were sudden infant death syndrome for 12, infection for 3, and 1 case each of intracerebral hemorrhage, accidental suffocation, and congenital heart disease. Conclusion: Few neonatal deaths following HepB vaccination have been reported, despite the use of at least 86 million doses of pediatric vaccine given in the United States since 1991. While the limitations of passive surveillance systems do not permit definitive inference, these data suggest that HepB immunization is not causing a clear increase in neonatal deaths.Recombinant hepatitis B vaccine and the risk of multiple sclerosis NEUROLOGY 2004;63:838-842A prospective studyMiguel A. Hernán, MD, DrPH, Susan S. Jick, DSc, Michael J. Olek, DO and Hershel Jick, MDFrom the Department of Epidemiology (Dr. Hernán), Harvard School of Public Health, Boston; Boston Collaborative Drug Surveillance Program (Drs. Susan S. Jick and Hershel Jick), Boston University, Lexington, MA; and Department of Neurology (Dr. Olek), College of Medicine, University of California, Irvine.Background: A potential link between the recombinant hepatitis B vaccine and an increased risk of multiple sclerosis (MS) has been evaluated in several studies, but some of them have substantial methodologic limitations.Methods: The authors conducted a nested case-control study within the General Practice Research Database (GPRD) in the United Kingdom. The authors identified patients who had a first MS diagnosis recorded in the GPRD between January 1993 and December 2000. Cases were patients with a diagnosis of MS confirmed through examination of medical records, and with at least 3 years of continuous recording in the GPRD before their date of first symptoms (index date). Up to 10 controls per case were randomly selected, matched on age, sex, practice, and date of joining the practice. Information on receipt of immunizations was obtained from the computer records.Results: The analyses include 163 cases of MS and 1,604 controls. The OR of MS for vaccination within 3 years before the index date compared to no vaccination was 3.1 (95% CI 1.5, 6.3). No increased risk of MS was associated with tetanus and influenza vaccinations.Conclusions: These findings are consistent with the hypothesis that immunization with the recombinant hepatitis B vaccine is associated with an increased risk of MS, and challenge the idea that the relation between hepatitis B vaccination and risk of MS is well understood.Received March 31, 2004. Accepted in final form May 8, 2004.“Multiple sclerosis and hepatitis B vaccination: Adding the credibility of molecular biology to an unusual level of clinical and epidemiological evidence” Comenge Y; Girard M (Med Hypotheses, doi 10.1016/j.mehy.2005.08.012)“Autoimmune hazards of hepatitis B vaccine” Girard M (Autoimmun Rev 2005; 4:96-100) (Text available in electronic form on request.)______________________________________Low Prevalence in The UK of Hepatitis B and Infections acquired abroadThe prevalence of hepatitis B infection in adults in England and Wales - Epidemiology and Infection (1999), 122:133-138 Cambridge University PressCost effectiveness analyses of alternative hepatitis B vaccination programmes in England and Wales require a robust estimate of the lifetime risk of carriage. To this end, we report the prevalence of infection in 3781 anonymized individuals aged 15–44 years whose sera were submitted in 1996 to 16 microbiology laboratories in England and Wales. One hundred and forty-six individuals (3·9%) were confirmed as anti HBc positive, including 14 chronic carriers (0·37%). The prevalence of infection and carriage was higher in samples collected in London and increased with age. No increased risk of infection was seen in sera from genito-urinary (GUM) clinics. Only 15 sera positive for hepatitis B were also positive for hepatitis C. Our results confirm the low prevalence of hepatitis B in England and Wales, are consistent with previous estimates of carriage and suggest that many infections were acquired while resident outside the UK. Future prevalence studies should determine the country of birth and other risk factors for each individual in order to confirm these findings. (Accepted September 14 1998)